CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Mozobil (plerixafor) for Peripheral Blood Stem Cell (PBSC) Mobilization — Coverage Criteria

Defines accepted indications, contraindications, exclusions, dosing limits, and documentation requirements for plerixafor (Mozobil) use for PBSC mobilization in patients undergoing autologous transplantation. Applies to providers requesting authorization through Evolent on behalf of Neighborhood Health Plan of Rhode Island members.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyMozobil (plerixafor) for PBSC mobilization — covered with criteria

Policy CodePolicy N/A

Change TypeTemplate conversion and exclusion criteria update

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization through Evolent for plerixafor requests; continuation may be exempt if no disease progression and prior use within the last year without >30-day lapse.

SourceLink

POLICY UPDATE CHANGES

Converted to new Evolent guideline template and updated exclusion criteria and references.

Removed phrase identifying a preferred short-acting MGF (Zarxio or Granix) from the indication section.

J2562HCPCS code for plerixafor (mg)

0.24 mg/kgsingle dose maximum

20 mgweight-based cap ≤83 kg

40 mgweight-based cap >83 kg

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Coverage Criteria for Plerixafor (Mozobil)

Initial therapy / Approved indication

Covered when ALL of the following are met

Indication: Patient has non-Hodgkin's lymphoma or multiple myeloma and is undergoing autologous stem cell transplantation requiring peripheral blood stem cell (PBSC) mobilization

Supported by FDA labeling and compendia/guidelines

Regimen: Plerixafor (Mozobil) is used in combination with a short-acting myeloid growth factor (MGF) given on 4-5 days of MGF with or without chemotherapy for mobilization

Policy specifies combination use rather than monotherapy

Supporting evidence: Use is supported by FDA product labeling, CMS-recognized compendia, NCCN or ASCO clinical guidelines, or peer-reviewed literature meeting CMS standards

See references: prescribing information, NCCN, ASCO, Medicare Benefit Policy Manual Chapter 15

Regimen	Indication	Coverage status	Notes / Limits
Plerixafor plus short-acting myeloid growth factor (MGF) with chemotherapy mobilization (MGF given on 4-5 days of mobilization)
Peripheral blood stem cell (PBSC) mobilization for members with non-Hodgkin's lymphoma or multiple myeloma undergoing autologous transplantation
covered
Plerixafor must be used in combination with a short-acting MGF and chemotherapy mobilization. Single dose limit: 0.24 mg/kg. Weight-based maximum dose caps: ≤83 kg = 20 mg; >83 kg = 40 mg. Not covered as monotherapy; treatment must not exceed maximum consecutive days per policy.

Coverage for Mozobil (plerixafor) is limited to use in combination with a short-acting myeloid growth factor (MGF) and chemotherapy for peripheral blood stem cell (PBSC) mobilization in patients undergoing autologous transplantation (e.g., multiple myeloma or non‑Hodgkin's lymphoma). Requests will be denied if Mozobil is used as monotherapy rather than as an adjunct to G‑CSF/short‑acting MGF and appropriate mobilization chemotherapy (see regimen and documentation requirements).

Dosing must adhere to policy dose limits: a single dose must not exceed 0.24 mg/kg, with weight‑based caps of 20 mg for patients ≤83 kg and 40 mg for patients >83 kg. Requests that exceed these thresholds or that propose treatment beyond the policy's maximum consecutive days will be excluded/denied.

Authorization requires supporting documentation consistent with FDA labeling and accepted compendia/guidelines (e.g., NCCN, ASCO) or peer‑reviewed literature meeting CMS standards. Provide evidence that the planned use aligns with the combination mobilization regimen, patient diagnosis (autologous transplant candidates with multiple myeloma or non‑Hodgkin's lymphoma), and the dosing/duration limits stated above.

Use of Mozobil (plerixafor) for off‑label or investigational indications is considered not medically necessary when the supporting evidence is insufficient or not generally accepted by the medical community. Insufficient evidence includes inadequate representation of the patient or regimen in published studies, lack of clinically meaningful outcomes (for example, failure to meet commonly accepted thresholds such as hazard ratios <0.80 or survival benefits of at least 3 months for OS/PFS), poor study design for the question being asked, reliance solely on case reports or meeting abstracts without full peer‑reviewed publication, or absence of support in CMS‑recognized compendia.

Requests for investigational/off‑label use must include robust supporting literature that meets the policy's evidentiary standards; otherwise the request will be denied under the policy's exclusion criteria.

Coding and Dose Limits

HCPCS CodesHCPCS

J2562

Injection, plerixafor, mg

inv-05: Single dose limit — 0.24 mg/kg

Single dose limit0.24 mg/kg

ContextDosing above this single-dose limit is an exclusion criterion and may result in denial of coverage.

Related codeHCPCS J2562 (Injection, plerixafor, mg)

inv-06: Maximum dose by weight — ≤83 kg: 20 mg; >83 kg: 40 mg

Maximum dose if weight ≤ 83 kg20 mg

Maximum dose if weight > 83 kg40 mg

Policy note

Authorization, Documentation, and Denial Triggers

Prior Authorization

Authorization and continuation rules

Prior authorization required through Evolent for all requests. Evolent is responsible for processing medication requests from network ordering providers; medications not authorized by Evolent may be deemed not approvable and not reimbursable.

Prior authorization required via Evolent for initial requests and renewals.
Continuation requests exempt from prior authorization review if all continuation conditions are met (member has not experienced disease progression on the requested medication; the medication was used within the last year without a lapse >30 days of active authorization; no additional medications are being added to the continuation request).

Documentation Required

Combination therapy requirement

Mozobil (plerixafor) must be used as part of combination therapy for peripheral blood stem cell (PBSC) mobilization. Specifically, plerixafor is indicated for use in combination with a short-acting myeloid growth factor (MGF) with or without chemotherapy for mobilization in members with non-Hodgkin's lymphoma or multiple myeloma undergoing autologous transplantation.

Key Definitions

inv-12: Peripheral Blood Stem Cell (PBSC) Mobilization — definition of mobilization regimen

DefinitionUse of plerixafor (Mozobil) as a hematopoietic stem cell mobilizer in combination with a short-acting myeloid growth factor (MGF) given on 4–5 days of MGF ± chemotherapy to mobilize peripheral blood stem cells for collection prior to autologous transplantation.

Indicated populationsMembers with non-Hodgkin's lymphoma or multiple myeloma undergoing autologous transplantation.

Regimen requirementPlerixafor must be used in combination with short-acting MGF (and chemotherapy mobilization when applicable); monotherapy is an exclusion.

Line of Therapy / Salvage Use

salvage

Line of therapy: Use in patients undergoing autologous transplantation for PBSC mobilization (peri‑transplant mobilization setting)

Used as a mobilization adjunct; not specified as first‑ or second‑line systemic therapy

Background

Plerixafor (Mozobil) is a hematopoietic stem cell mobilizing agent used to augment peripheral blood stem cell (PBSC) collection prior to autologous transplantation. It is administered in combination with a short‑acting myeloid growth factor (such as G‑CSF) and mobilizing chemotherapy when needed to increase the number of circulating hematopoietic stem cells for collection and subsequent transplant.

Clinical use is focused on patients with multiple myeloma and non‑Hodgkin's lymphoma undergoing autologous stem cell transplant, where plerixafor is given as part of a mobilization strategy to improve PBSC yield after G‑CSF (and chemotherapy) mobilization attempts.